Information about Military and Civilian Biodefense/Terrorism Countermeasures, vaccines, laws and policies

August 30, 2004

Needle-Free Anthrax Vaccine in the Works

ForbesBy Randy Dotinga, HealthDay Reporter

MONDAY, Aug. 30 (HealthDayNews) -- Scientists say they've moved closer to developing a powdered vaccine for anthrax that could be given through the nose, providing a safer, easier way to protect people from the potential bioterrorism weapon.

So far, the researchers have only confirmed that the needle-free vaccine appears to work in rabbits. But they're hopeful that future tests in animals and humans over the next two to three years will be successful.

"This is not a cure for anthrax, but may be a better means of protecting at-risk populations from infection," Vince Sullivan, a chemist at BD Technologies, said in a statement. His company is developing the vaccine in conjunction with the U.S. Army.

Researchers described the vaccine last week at the annual meeting of the American Chemical Society in Philadelphia.

Anthrax became a household word in 2001, shortly after the 9/11 attacks, when someone mailed infected packages to news organizations and government officials.

Anthrax spores occur normally in nature, particularly in dirt, but they usually infect few people in the United States. However, the inhalation form of anthrax is especially deadly, and experts say terrorists could potentially infect thousands of people with a small supply of the germ.

The anthrax vaccine protects most people who get it via six injections over an 18-month period. The vaccine hasn't been given to the general public; those who get it include members of the military, laboratory workers and people who work with animals.

Critics charge the anthrax vaccine is too dangerous, and controversy has arisen over whether soldiers should be able to refuse the shots.

New technology offers the chance to perfect the vaccine and make it easier for people to tolerate, said Dr. Henry Shinefield, co-director of the Kaiser Permanente Vaccine Study Center, in Oakland, Calif. Nasal vaccines in particular have become more popular in recent years as scientists developed ways to "deliver" antibodies -- germ fighters -- into the body in ways other than injections. Last year, the federal government approved the first nasal flu vaccine.

The body absorbs substances in many ways, including through nasal membranes, the skin or the intestines, Shinefield said. One possible benefit of nasal vaccines is that they may be more convenient than giving several shots, he said.

The researchers who are developing the nasal anthrax vaccine say it comes in a dry powder that can be administered into the nose without the aid of a nurse.

In tests, between 83 percent and 100 percent of vaccinated rabbits survived exposure to lethal doses of inhalation anthrax, according to the researchers. Researchers report that the existing vaccine provides a similar level of protection.

It's not clear how many doses of the nasal vaccine would be required to provide protection.

Even if the vaccine turns out to be effective, safety will be a prime concern, Shinefield said. "We're sophisticated enough now to know that you can't make assumptions. You want to be sure that every vaccine is not only effective but as safe as it can possibly be."

August 25, 2004

'I want to be healthy again' - Visalian says anthrax vaccine ended his Air Force career

Visalia Times-Delta, CABy David Castellon, Staff writer

As a teenager graduating from Visalia's Mt. Whitney High School in 2000, Wess Hardin had plans for his future. Those plans included time in the Air Force and maybe being a police officer. The 22-year-old says he believes a vaccine that was supposed to protect his life has de-railed those plans.

"This sucks. I want to be healthy again," said Hardin, sitting in the diningroom of his parents' Visalia home. He has lived with his parents since beinghonorably discharged from the Air Force in December 2002, just a year-and-a-half into his initial four-year enlistment.

He said he was honorably discharged over a "failure to adapt" to Air Forcelife. But that "failure" was tied into a bout of alcoholism, mood swings andtalking back to superiors.

However, Hardin said, the drinking and aggressive behavior aren't rooted ina bad attitude. In-stead, he said they stemmed from a series of healthproblems, which included dizziness, depression, chest pains, seizures, adiagnosed bipolar disorder, poor memory retention and some hair loss that hedidn't suffer from until after he began receiving injections of the military's controversial an-thrax vaccine.

"Wess wasn't this way before. He was articulate," said his father, DelHardin, a retired Tulare County sheriff's deputy.

He referred to the lethargic, almost sleepy way that his son moves andtalks, and his frequent lapses of short-term memory, like somebodyintoxicated or on drugs. Wess Hardin said he no longer drinks, thoughoccasionally he does smoke marijuana.

But it's the depression and lack of energy -- "I wish I had energy" -- thathe said has affected his demeanor and speech.

"That just sounds so unlike him," said Marlin Roehl, who taught HardinAmerican literature at Mt. Whitney. "I mean, every day he was full of energy, enthusiasm, good humor. He always had plans. ... I don't think I ever saw him down."

Hardin isn't alone in claiming that the anthrax vaccinations have causedhealth problems, many of the sort Hardin described. The vaccinations are aseries of shots required for all military members deployed to high-threatareas, including the Persian Gulf.

From the beginning, the shots have caused controversy, largely about safetyconcerns. Some reactions by people who have been injected with the vaccinehave been so severe and debilitating they require hospitalizations andmedical discharges from the services.

Hardin knew of the controversy before he took his first anthrax shot beforebeing deployed to Saudi Arabia in 2002, and even considered refusing.

Del Hardin, who also served in the Air Force, also was concerned about theshots' safety. But he ended up encouraging his son to get the injectionsrather than risk being drummed out of the Air Force or face court-martialfor disobeying a direct order.

At first, Wess Hardin seemed to suffer no ill effects. But upon his returnfrom Saudi Arabia, Del Hardin said he noticed subtle changes in his son thatjust got worse. "He sounded sick all the time" and complained of body aches,dizzy spells and congestion in his throat, the senior Hardin said.

He grew concerned enough that he went online and found a list of ailmentsreported by people claiming adverse anthrax vaccine reactions. The ailmentswere so consistent with those his son was experiencing that he became convinced the vaccine was the culprit.

But convincing the Air Force was a different matter.

"I saw a mess of [Air Force] doctors," Wess Hardin said, and they couldn'tdetermine a cause for his condition except to say, "It's in my head. Anxiety."

And tests by civilian doctors -- including one two weeks ago after he againsuffered chest pains -- have been similarly inconclusive, he added.

Some of the people medically separated from the military over vaccinereactions have received disability pay and ongoing medical care.

Hardin said his discharge wasn't medical, so he got no such benefits. Hesaid he has to live with his parents because his health problems have madeit hard to hold down a job or to aspire to go back to college or trade school.

Even driving is off limits to him because of the risk he could have a seizure behind the wheel.

And since leaving the Air Force, Hardin said he has done little to try toseek financial or medical assistance from the military, in part because hebelieves "they're not going to help me."

But Kathy Hubbell, president and founder of the Military Vaccine EducationCenter, a watchdog group providing information on the anthrax vaccine andcounseling to military members, disagreed.

"He needs to apply to the [Veterans Affairs] system for disability. He needsto start with his local VA chapter," she said.

In addition, she said, Hardin needs to make sure he files a Vaccine AdverseEvent Reporting System report with the Food and Drug Administration and theCenters for Disease Control and Prevention, which track adverse reactions tovaccines.

"And he needs to write everything he went through down on paper. We recommend people keep a daily journal ... because that's the only way you may be able to prove to the VA that [the health problems are] related to the shots.

"It's going to be a long fight. It sometimes takes the VA a couple of yearsto kick in."

Del Hardin said he wants the military to give his son treatment for hisailments. But he also wants parents to know that if their children join themilitary there is a risk that comes from rolling up their sleeves and takingthe anthrax vaccine.

"I believe young adults have a responsibility to their country, but theyshould not be treated as cattle," and they should have the right to refusethe vaccine, he said.

August 24, 2004

Inhaled anthrax vaccine protects animals

WASHINGTON (Reuters) - A powdered anthrax vaccine that people potentially could take by themselves protects rabbits against the deadliest form of the bacteria, researchers say.

Developed jointly by U.S. Army researchers and BD Technologies, the vaccine works about as well as current injected versions, the scientists said on Tuesday.

"Our intranasal powder vaccine discovery may provide a highly effective, more flexible, mobile and easy-to-use method of administering the anthrax vaccine in clinical and field settings," said Vince Sullivan, a chemist with BD Technologies who led the study.

The company, a unit of syringe-maker Becton Dickinson and Company, said tests on people could be possible within two to three years.

Anthrax, normally a disease of livestock and wild animals, is considered a top bioterror threat by U.S. experts. Anthrax spores were used in a series of 2001 letter attacks that killed five people -- a crime that remains unsolved.

Anthrax infection is easily cured with the use of antibiotics, but in cases of the inhaled form, by the time symptoms appear it is often too late to treat the patient.

Conventional anthrax vaccines are injected over a series of months. U.S. defence officials say 1 million service members have been vaccinated, but they are seeking an easier-to-administer vaccine.

BioPort, a privately held company based in Lansing, Michigan, is the main maker of the current anthrax vaccine.

For their study, the researchers created a genetically engineered vaccine based on one main anthrax protein called protective antigen. They powdered it an gave it to rabbits as an aerosol.

They then made the rabbits inhale anthrax spores, which can cause a fatal infection.

Between 83 percent and all the rabbits survived, they told a meeting of the American Chemical Society in Philadelphia.

August 23, 2004

Review board grants few medical retirements

by Karen Jowers - Army Times

Staff Sgt. Dwayne Fitzpatrick has nothing but praise for the doctor who treated him at Fort Stewart, Ga., in the first steps of the Army’s process to determine if he was fit to continue on duty. He has a different opinion about the bureaucracy. In May, a physical evaluation board notified Fitzpatrick, who has been diagnosed with fibromyalgia, a disorder that causes widespread muscle pain and fatigue, that it had decided to rate him 20 percent disabled. That is 10 percentage points shy of what is needed for medical retirement.

Officials in the patient affairs division of the hospital then offered him a lump sum of about $23,000, Fitzpatrick said. “That was what I was worth, and she came up with that figure pretty quickly,” said Fitzpatrick, of Orlando, Fla., an 11-year Florida National Guard veteran who deployed to Saudi Arabia in 2002.

After he discovered errors in the packet that was submitted, including the fact that most of the doctor’s documentation was removed, Fitzpatrick appealed. He presented the new information, including the doctor’s original information, to the board at the beginning of June.

Fitzgerald won the appeal, receiving a disability rating of 40 percent, and was medically retired on July 15. He now receives $1,234 a month.

“We don’t care about the amount of money,” Fitzpatrick said. “We just want our medical care. I’ve met about 25 to 30 people, and only three of us have gotten 30 percent or more. The others are 10, 20, or zero percent. Six appealed their decisions and they were left unchanged.”

Although the military does a good job taking care of those with serious injuries that are visible, such as loss of limbs, “they’re doing a bad job compensating people for things you can’t see,” said Steve Robinson, executive director of the National Gulf War Resource Center.

If a soldier is determined to have at least a 30 percent disability, he is medically retired. But if the soldier does not have at least 20 years of service, anything less than a 30 percent rating can result only in a severance payment.

According to an Army information paper, disability severance pay is equal to two months’ basic pay for each year of service, up to a maximum — at most, 24 months of basic pay.

“When they’re medically retired or take severance, it goes against the Defense Department budget,” Robinson said. “It looks as if DoD may be saving money by not correctly evaluating these soldiers, and that’s going to hurt them down the road.”

A ‘performance-based’ system

“The physical evaluation board is a performance-based system,” Col. Fred Schumaker, executive officer of the Army Physical Disability Agency, said in an e-mail response to questions.

“What the board does is take a look at the diagnoses, rates those that are listed as falling below standards and makes an independent determination if that condition itself leads to the physical unfitness of the soldier,” Schumaker said. “If the answer to that is yes, it is rated. If the answer to that question is no, the condition is not rated. This is established by law.”

The services rate only the “unfitting conditions,” he said.

Since Oct. 1, the Army’s Physical Disability Agency has received about 8,200 cases for determination of whether a soldier was physically fit to continue duty, said Lt. Col. Kevin Arata, spokesman for the Army Human Resources Command. Of those, 59 percent were separated with severance pay, which means the Army ruled their disability was less than 30 percent.

Only 8 percent were permanently retired.

Of the others, 10 percent were separated without benefits; 17 percent were placed on the temporary disabled retirement list, where they can remain for up to five years; and 6 percent were found fit for duty.

Along with underrating troops’ conditions, Robinson contends the medical board process takes too long, leaving troops in limbo about their future. “It’s unconscionable that you could survive Iraq and come back and wait 10 to 16 months” for resolution, he said.

But medical evaluation results are not forwarded to the Army Physical Disability Evaluation System until the soldier has received whatever medical care he needs, Arata said.

“In the medical community, we take the time necessary to treat the soldier fully and bring the soldier to optimal health before forwarding Medical Evaluation Board results,” he said. “The system is designed to give soldiers every opportunity to get well and return to duty.”

In the third quarter of fiscal 2004, ending in June, the average medical board processing time was 83 days, Arata said.

August 20, 2004

National Preparedness Strategy to be Debated at RNC Security Roundtable in NY

WASHINGTON, Aug. 20 /PRNewswire/ -- Increased uniformed security, more checkpoints and additional barricades were all tangible signs that American cities were heeding the warnings earlier this month of a heightened terrorism alert, Code Orange, sounded by the federal Department of Homeland Security.

Despite the relevant information and subsequent terror threat warning, civilians and local government officials still concede the federal government should be doing more to better equip our nation's cities and their police, fire and emergency first responders.

Key members of the House Select Committee on Homeland Security will join a diverse group of governors, mayors, police, emergency services officials and terrorism experts to discuss this and other new homeland security challenges Tuesday, August 30th, at 10 a.m. at the Hilton New York, 1335 Avenue of the Americas, during the Republican National Convention in New York City.

The discussion will focus generally on American preparedness and the role of Federalism in supporting homeland security funding for cities and states to protect against another terrorism attack, particularly bio-terror. The forum is being hosted by Lansing, Michigan-based BioPort Corporation, makers of the only FDA-approved and licensed anthrax vaccine, BioThrax, which has been used to immunize more than 1.1 million U.S. military service members during the past six years.

As the presidential elections approach, security analysts are predicting the likelihood of another terror attack on U.S. soil, particularly bio-terror, is high. As part of his administration efforts to address this President George W. Bush recently signed into law, Project Bioshield, a $5.6 billion, 10-year initiative which gives the government the authority to create and stockpile drugs to fight bio-terrorism.

"There is a significant world-wide demand for anthrax vaccine for the protection of both military and civilian populations, including first responders," Bob Kramer, the company's president, said. "We're looking forward to this opportunity to hear from a significant number of people who have shared interests," he said.

Wrangling Impedes Transfer Of Civilian Anthrax Vaccine

New York TimesBy JUDITH MILLER

Despite pledges two years ago to maintain a stockpile of drugs to protect Americans in the event of a bioterrorism attack, the federal government has so far set aside only 159 vials of anthrax vaccine for the civilian population enough for only 530 people, according to congressional and administration officials.

The officials said the failure to transfer more of the vaccine from military to civilian control was caused by legal and bureaucratic wrangling among government agencies. They also cited the government's desire to buy a new vaccine that is potentially both cheaper and more efficient. That vaccine has not yet been approved by the Food and Drug Administration.

Spokesmen for the Pentagon and the Department of Health and Human Services denied that the delay would imperil the well-being of civilians, saying that BioPort, the nation's sole producer of licensed anthrax vaccine, was storing nearly a million doses -- enough for more than 330,000 people.

''The bottom line is: if there is a civilian crisis that would require vaccination of the population, there is enough anthrax vaccine to do that,'' said Bill Pierce, a spokesman for the Department of Health and Human Services. ''It would just take a phone call to get that vaccine transferred from the Pentagon to the stockpile,'' he said, dismissing the delays to ''paperwork that will get done.''

But a spokesman for BioPort and Pentagon officials said that the doses being stored are intended for the military, which announced in June that it was expanding its anthrax and smallpox vaccination program. If those doses were used by civilians in an emergency, officials said, military vaccinations would have to be curtailed or scaled back.

Michael Zamiara, the chief financial officer of BioPort, in Lansing, Mich., said the military had first call on its vaccine. ''We must run a business,'' he said. While the Department of Health and Human Services had indicated it wanted the vaccine for the civilian stockpile, he said, the agency had yet to ''pay us for it, or tell us how much it wants to buy.''

Officials also said that the Bush administration had not implemented an interagency agreement signed last April, a copy of which was provided to The Times, in which the Pentagon agreed to provide at least two million doses of anthrax vaccine to the civilian stockpile by the end of this fiscal year, or Sept. 30.

'It is a shocking lack of preparedness to have only 159 vials set aside for civilian use when we know that Al Qaeda would not hesitate to launch an anthrax attack against the United States,'said Rep. Jim Turner, Democrat of Texas, the ranking member of the House select committee on homeland security, which has been investigating the state of the nation's strategic stockpiles.

Jerome Hauer, a former assistant secretary with the Department of Health and Human Services in the Bush administration, said the months of infighting over such issues as who would indemnify BioPort for its vaccine reflected a lack of priority on biodefense.

'We now have bureaucrats and lawyers running bioterrorism preparedness,' said Mr. Hauer, who heads a biodefense center at George Washington University.

The vaccine issue has been complicated by Congress's recent transfer of control of the civilian stockpile from the Department of Homeland Security back to the Department of Health and Human Services.

Many scientists at the health agency favor a new recombinant vaccine that may require fewer shots and be faster to make.

August 19, 2004

FDA Plans Use of Unapproved Drugs in WMD Events

By Joe FiorillGlobal Security Newswire

WASHINGTON — The U.S. Food and Drug Administration has begun preparing for the use of otherwise unapproved vaccines and treatments in the event of a WMD emergency.The agency is drafting guidelines on an emergency-use capability authorized in the Project Bioshield law signed a month ago by President George W. Bush, FDA Assistant Commissioner for Counterterrorism Margaret Glavin said last week (see GSN, July 21).“You can’t anticipate every possible situation, so what we’re trying to do is to lay out a thought process, rather than specific procedures and specific decision rules,” Glavin said in an interview.The agency, which takes an average of 12 years to approve drugs for use in the United States, is developing the emergency-use guidelines in consultation with other bodies that would be involved in administering the unapproved drugs. The goal, Glavin said, is for the agencies to reach a “common understanding of what the boundaries are.”

The best-publicized component of Bioshield is the creation of a government-guaranteed market for otherwise unprofitable WMD countermeasures, which drug makers do not currently produce in quantities sufficient for a large attack.

A separate provision of the new law allows the health and human services secretary to declare a one-year emergency, in the event of a WMD attack on the United States, during which drugs that lack FDA approval or are approved for other purposes may be used to combat biological or chemical agents or radiation.

Although the health secretary is responsible for formally declaring any emergency under the provision, the determination that the declaration is needed can also originate with the defense or homeland security secretary. The health secretary must also consult with the heads of the National Institutes of Health and Centers for Disease Control and Prevention before authorizing any specific unapproved product for use in a given emergency.

Glavin said her agency would be central in any emergency-use decisions. “We see the authorizations as coming from the [FDA] commissioner under existing … authority. … We would be the operating entity within HHS to do the work on it,” she said.

Liability Questions Remain Unresolved

Even though Bioshield is now law, the legal status of emergency-approved drugs under the legislation remains unclear, potentially limiting the law’s effectiveness in sparking drug development (see GSN, July 26). “Bioshield II” legislation planned for later this year by Senators Joe Lieberman (D-Conn.) and Orrin Hatch (R-Utah) would address matters including manufacturers’ concerns about legal liability for damages from Bioshield-related drugs.

Meanwhile, the FDA is considering the creation of a new regulatory category for otherwise unapproved drugs that are potentially useful in a WMD emergency, according to Bioshield expert Stephen Prior, who directs the National Security Health Policy Center at the Potomac Institute for Policy Studies. Providing such a status to certain drugs could ease liability concerns and smooth the emergency-authorization process in time of need.

The usefulness of a new drug category is clear, Prior said yesterday in an interview. If an attack warranting an emergency-use authorization occurred tomorrow, he said, the current legal uncertainty could necessitate a presidential order accepting total government liability for damages.

“That’s not a good way to go for the government, to just take on unwarranted levels of indemnification, but they will do that in an emergency if there’s no other recourse,” Prior said.

Bioshield stipulates that the health secretary “may” impose conditions on emergency use that include informing patients of the option and possible consequences of refusing emergency-authorized drugs.

Such measures would probably be less cumbersome than those commonly taken for medicines granted an existing investigational new drug status, which allows activities such as transporting unapproved drugs across state lines and testing them on consenting subjects. Bioshield stipulates that authorizing drugs for emergency use does not grant them investigational new drug status.

National Institute of Allergy and Infectious Diseases Director Anthony Fauci last year told a House of Representatives subcommittee that, although investigational new drugs could sometimes be used in emergencies under existing laws, the amount of paperwork they required would prevent large-scale use.

“If you have to vaccinate 10 million people,” Fauci said, “there isn’t a chance that you’re going to be able to do that under an investigational new drug, so what the [Bioshield emergency-use] proposal says is that [there can be] something between a full licensure and something that is an investigational drug.”

According to Prior, the Bioshield emergency-use authorization could lead to storage of unapproved drugs in the Strategic National Stockpile of emergency countermeasures, potentially resolving a long-standing debate over the legality of including investigational new drugs in the stockpile. FDA rules that govern distribution of drugs should not apply to the stockpile, Prior said, since the stockpile “is only used under specific authorization” and “is not a general distribution system.”

“The purpose of the Bioshield legislation is to create an environment in which those products which could become part of the Strategic National Stockpile could be developed and, if necessary, purchased,” Prior said.

Glavin said Bioshield’s usefulness is in providing options for “circumstances where doing something is better than doing nothing.” Existing FDA powers such as the conferral of investigational new drug status, she said, would be of limited use in a large-scale emergency.

“They really don’t contemplate a mass-casualty situation,” she said, “and they don’t contemplate what Bioshield contemplates, which is an act of terror in which some larger number of individuals could be affected and in which time is of the essence.”A drug authorized in an emergency could carry risks, Glavin said, but the scenario implies that a greater and more immediate danger is already present. An unproven drug could be the only hope in such a situation, she said, “and it might be better to use it than not.”

August 16, 2004

‘That shot messed him up’

The walls are stripped bare, the furniture, pictures and awards are packed in storage, and the wheelbarrow and baskets overflowing with flowers that brightened the front yard have been given to neighbors. All that’s left for Staff Sgt. Eddie Norman to do is go to the finance office, turn in his military ID card and map the route from Fort Meade, Md., to San Antonio. There, he said, he’ll go to the Department of Veterans Affairs for health care and rehabilitation. Where his wife and three children will receive care in Texas is not yet known.

After nearly 15 years of service, Norman is being medically separated — not retired —from the Army for debilitating muscle and joint pain, stiffness and weakness that started after his anthrax vaccinations.

He’ll get a lump-sum payout, which under the Army’s formula works out to $66,319.20, or 24 months’ basic pay.

He had sought at least a 30 percent disability rating so that he could keep his military health care, commissary and exchange benefits.

“They’re supposed to take care of me. They are accountable for what’s happened to me,” said Norman, 38. “They’re not being accountable. They’re not holding good leadership.”

Norman keeps folders labeled “VA,” “SSI” and others in a brown casual briefcase. His stack of medical records includes his medical evaluation board results and 10 diagnoses. Three of those conditions — musculoskeletal pain, sleep apnea and clinical depression — prevent him from meeting military medical-retention standards, according to the documents.

But the Physical Evaluation Board, part of the Army’s personnel system, said only the musculoskeletal pain made him unfit for service, and the board rated him 20 percent disabled for that condition. The physical evaluation process follows Defense Department policy.

“I used to be perfectly healthy,” Norman said, sitting on a box in his living room, his cane lying next to him. “The illnesses I have now occurred while I was on active duty.”

But just because a doctor determines a service member doesn’t meet medical-retention standards does not automatically mean the condition makes the member unfit for service. And the Physical Evaluation Board rates only those conditions deemed to make someone unfit. Officers and enlisted personnel are treated the same.

The board is a “performance-based system ... the mere presence of a medical condition that falls below medical-retention standards does not mean that condition is unfitting,” said Army Col. Frederick Schumacher, executive officer of the Army Physical Disability Agency.

“What the board does is take a look at the diagnoses, rates those that are listed as falling below retention standards and makes an independent determination if that condition itself leads to the physical unfitness of the soldier. If the answer to that is yes, it is rated. If the answer to that question is no, the condition is not rated,” Schumacher said. “This is established by law. The services only rate the unfitting conditions.”

Norman, a 1991 Persian Gulf War veteran, had some memory problems and muscle and joint pain in the mid-1990s, but recovered and was functional, scoring well on physical tests and completing classes, he said.

His muscle and joint pain flared and worsened after his anthrax vaccinations. He lost some muscle control in his hands and legs, he said, and has suffered depression over his physical condition.

Documents from military medical exams link the problem to the time of his anthrax shots, but cannot conclude the shots caused the problem. Vaccine health care experts say they have seen similar cases following vaccinations.

“Staff Sgt. Norman was a high-functioning, decorated service member prior to beginning anthrax vaccine,” stated a document from the Walter Reed National Vaccine Healthcare Center in Washington. “Staff Sgt. Norman’s life has been significantly altered due to his current disability and hope for recovery is uncertain. The lack of clinical findings is discouraging and leaves his providers baffled and powerless as to an effective treatment plan.”

According to the document, the Vaccine Healthcare Center has treated “many proficient service members with debilitating conditions that cannot be diagnosed or medically substantiated, conditions that have developed in close temporal association to having received the anthrax as well as other vaccines.”

Norman got all six anthrax shots under the mandatory program. He received his first while preparing for deployment to South Korea. Afterward, he said, his hips hurt and he couldn’t turn his neck. His health grew worse after each shot, he said, and he suffers from muscle cramps, numbness in his legs, ringing in his ears, poor sleep, diabetes and other problems.

“That shot messed him up,” his wife, Regina, said. “Before he could play with the children, jump rope, trampoline, everything. Now he can’t do those things with the kids.”

Norman would tell his daughters they could go to a friend’s house, forget he’d said it and then get angry when they weren’t home.

He still uses a cane to walk, wakes in pain sometimes in the middle of the night, and gets confused and frustrated. His legs hurt — especially his right leg, which, he said, shakes uncontrollably at times and “hurts terrible.”

The former light tactical wheel mechanic with the 1st Infantry Division hasn’t worked his job in more than three years. His involuntary separation because of permanent physical disability begins this month.

In San Antonio, the family will be closer to friends and extended family members. Norman said his next step is to see a VA rehabilitation counselor to learn what jobs he can do and try to go to vocational school.

“I feel like everything I really worked for is lost,” Norman said. “All my time in service, honorable time in service, that I worked hard for, is wasted.”

August 12, 2004

Pneumonia again hits troops in Middle East

by Sandra Jontz Stars and Stripes, European Edition

ARLINGTON, Va. — Cases of pneumonia continue to plague troops deployed to the Middle East, and the number of “severe” cases, in which troops are put on ventilators, mirrors the number of this same time last year when the disease baffled health officials.Eight servicemembers this year have contracted pneumonia and have shown a higher than usual number of a white blood cell type called eosinophils, one of the few facts that has linked the various cases, said Dr. (Col.) Bruno Petruccelli, director of the Epidemiology and Disease Surveillance Directorate at the Army Center for Health Promotion and Preventive Medicine.

Of the eight, six had to be placed on ventilators, he said.

The body produced eosinophils to fight infection or when a person suffers from asthma, hay fever or other types of allergies.

Last year, between March and August, 19 servicemembers contracted the illness and were treated in intensive care units and placed on ventilators. Of those 19, 10 showed a higher than usual number of eosinophils. Two of the pneumonia cases were fatal. This year, there have been no fatalities.

Pneumonia is an infection or inflammation of the lungs in which air sacs fill with liquid and prevents oxygen from reaching the body’s blood supply.

What is different this year from last, is that doctors are treating pneumonia patients earlier with steroids, which decreases the time they must spend in intensive care units and hospitals, said Petruccelli, whose specialty is preventive medicine.

While he can’t make a medical connection between steroids being use earlier and the fact that there have been no fatalities, “indirectly, the earlier use of steroids means shorter hospital stays and shorter hospital stays reduces the chance of complications from medical care.”

In spite of aggressive medical efforts to keep troops from contracting the disease, Petruccelli said he’s “not surprised at all” by the number of cases. “It’s relatively few people when you think we have about 150,000 people there.”

The Army, for example, sees about 400 to 500 cases of pneumonia worldwide each year. Between 1998 and 2002, 17 soldiers worldwide died of pneumonia or complications of pneumonia.

The number of cases in the theater seems to be more prevalent in the spring and summer months, however, the Army did log its first case this year in January after a four-month lull at the end of 2003.

“It looked like it mysteriously came to a halt,” Petruccelli said.

The cases involving eosinophils baffles medical experts because there is no known cause, no known pre-existing condition that might make one person more susceptible than other, nor any guaranteed preventions, he said.

However, experts have noted that among the more severe cases, troops not only were smokers, but had started smoking once arriving in theater, which might have made their bodies slightly more susceptible to contracting the pneumonia, he said.Respiratory problems are common among troops serving in Iraq, Kuwait and Afghanistan, enhanced in part because of the powder-fine dust and sandstorms in the region.

Army health officials have circulated a list of recommendations to help stave off contracting the illness:

• Stay hydrated• Don’t smoke; or at least smoke American cigarettes• Wash hands frequently• Use a cravat or dust mask to reduce dust inhalation• Use wet mops when cleaning dust in living and work areas• Seek medical care immediately for fever, chills and cough

August 9, 2004

Experts Say Civilian Smallpox Shots Not Needed

by Marina Malenic Global Security Newswire

WASHINGTON — Two former Bush administration advisers are no longer urging front-line U.S. health care workers to volunteer for smallpox vaccinations, even though they see no reduction in the threat from smallpox as a potential biological weapon (see GSN, July 14). It is the first time officials connected to the Bush adminstration have publicly said that no further immunizations are necessary.

“We don’t need to vaccinate the first-responders,” Donald Henderson, a former senior Health and Human Services Department adviser, told Time magazine last month.

Federal officials have distributed smallpox vaccine supplies nationally in sufficient quantities to enable first responders and other emergency medical personnel to receive the inoculation in time to protect them following an attack, said Henderson, who ran the World Health Organization program that eradicated smallpox in the 1970s and is now a professor of medicine at the University of Pittsburgh.

“The difference between now and where we were at 9/11, is that now we have a lot of vaccine, in a number of cities we have the capability to deal with an outbreak pretty quickly,” Henderson, who continues to advise Health and Human Services a part-time basis, told Global Security Newswire last week. “We are in a very different position,” he added.

“In an emergency we have the vaccine ready, and ready to move very quickly. Our first priority, the health care workers in emergency rooms that would be first in contact with the disease — 250,000 would fall into the category — could be vaccinated very quickly in case of an attack,” he said.

Two years ago, the Bush administration announced a smallpox vaccination program, with a target of inoculating 500,000 military personnel and 500,000 civilian health workers. The military program succeeded in meeting its goal and even surpassed it — more than 625,000 service members have received the vaccine — and the U.S. Defense Department last month expanded the effort to include all personnel deployed by U.S. Central Command and, for the first time, select units within U.S. Pacific Command (see GSN, June 30).

However, the civilian program never got off the ground due to concerns about the vaccine’s side effects, according to Jerome Hauer, a former Health and Human Services acting assistant secretary and director of the Response to Emergencies and Disasters Institute at George Washington University. While the administration encouraged millions of first responders and other medical professionals to volunteer for vaccinations (White House press release, Dec. 13, 2002), in the end fewer than 40,000 received the inoculation.

“I don’t know that there has been a huge policy reversal rather than that it just fell apart,” Hauer told Global Security Newswire last week.

Because no stockpiles of weapons of mass destruction have been found in Iraq since the end of the war, Hauer added, there has been no impetus to continue smallpox vaccinations.

“Once the war ended and no WMD were found — no smallpox, no biological agents — at the end of the day the sense of urgency waned,” he said. “People felt there was no need to go through the risk of being vaccinated unless the threat became immediate,” he added.

“The sense of urgency by the first responder community also waned,” Hauer said. “Barring something new, it would be extraordinarily difficult to get first responders vaccinated,” he added.

However, there is good reason to believe that biological warfare programs using smallpox remain a threat, Henderson said.

“At this point, the same factors that rated smallpox as high as it was are still there,” he said. Hauer agreed. “We were concerned about smallpox in the hands of terrorists well before Iraq,” he said.

Henderson explained that in the early 1990s a group of Soviet “bioweaponeers” said that smallpox was “at the top of their list” of biowarfare agents under development. “They admitted their intent to use smallpox in ICBMs and small bomblets for dispersal,” said Henderson, adding that some Soviet weapons scientists may have left those labs to work elsewhere (see GSN, Oct. 22, 2003).

“It’s hard to know who they are now working for,” he added.

Henderson said there are indications that other countries may be involved in such efforts as well.

“Soviet scientists at the time said that there had been activities with smallpox in North Korea,” he said.

“Whatever was going on or my have gone on in Iraq was not the only factor — we did not know anything more about Iraq than we did about Iran or Syria, for example,” he said. “It takes few people and not a lot of money to set up such a program. It’s not like nuclear work,” he added.

August 2, 2004

Soldier seeks answers in medical separation

by Deborah Funk Air Force Times

The walls are stripped bare, the furniture, pictures and awards are packed in storage, and the wheelbarrow and baskets overflowing with flowers that brightened the front yard have been given to neighbors.

All that’s left for Army Staff Sgt. Eddie Norman to do is go to the finance office, turn in his military ID card and map the route from Fort Meade, Md., to San Antonio. There, he’ll go to the Department of Veterans Affairs for health care and rehabilitation. Where his wife and three children will receive care in Texas is not yet known. After nearly 15 years of service, Norman is being medically separated, not retired, from the Army for debilitating muscle and joint pain, stiffness and weakness that started after his anthrax vaccinations.

“They’re supposed to take care of me. They are accountable for what’s happened to me,” said Norman, 38. “They’re not being accountable. They’re not holding good leadership.”

Norman keeps folders labeled “VA,” “SSI” and others in a brown casual briefcase. His stack of medical records includes his medical evaluation board results and 10 diagnoses. Three of those conditions — musculoskeletal pain, sleep apnea and clinical depression — prevent him from meeting military medical-retention standards, according to the medical documents.

But the Physical Evaluation Board, part of the Army’s personnel system, said only the musculoskeletal pain made him unfit for service and rated him 20 percent disabled for that condition. Norman needed a 30 percent disability rating to be medically retired, which would preserve his medical care and on-post shopping benefits.

“I used to be perfectly healthy,” Norman said, sitting on a box in his living room, his cane lying next to him. “The illnesses I have now occurred while I was on active duty.”

But just because a doctor determines a service member doesn’t meet medical-retention standards does not mean the condition makes the member unfit for service. And the Physical Evaluation Board rates only those conditions deemed to make someone unfit. The board is a “performance-based system ... the mere presence of a medical condition that falls below medical-retention standards does not mean that condition is unfitting,” said Army Col. Frederick Schumacher, executive officer of the U.S. Army Physical Disability Agency.

“What the board does is take a look at the diagnoses, rates those that are listed as falling below retention standards and makes an independent determination if that condition itself leads to the physical unfitness of the soldier. If the answer to that is yes, it is rated. If the answer to that question is no, the condition is not rated. This is established by law. The services only rate the unfitting conditions.” Norman, a 1991 Persian Gulf War veteran, had some memory problems and muscle and joint pain in the mid-1990s, but recovered and was functional, scoring well on physical tests and completing classes.

His muscle and joint pain flared again and got stronger after his anthrax vaccinations. He lost some muscle control in his hands and legs, he said, and has suffered depression over his physical condition. Documents from military medical exams link the problem to the time of his anthrax shots, but cannot conclude the shots caused the problem. Vaccine health-care experts say they have seen similar cases following various vaccinations.

“Staff Sgt. Norman was a high-functioning, decorated service member prior to beginning anthrax vaccine,” stated a document from the Walter Reed Regional Vaccine Healthcare Center in Washington.

“Staff Sgt. Norman’s life has been significantly altered due to his current disability and hope for recovery is uncertain. The lack of clinical findings is discouraging and leaves his providers baffled and powerless as to an effective treatment plan.”

The document said the Vaccine Healthcare Center has treated “many proficient service members with debilitating conditions that cannot be diagnosed or medically substantiated, conditions that have developed in close temporal association to having received the anthrax as well as other vaccines.”

Norman got all six anthrax shots under the mandatory program. He received his first while preparing for deployment to South Korea. Afterward, his hips hurt and he couldn’t turn his neck. His health grew worse after each shot, he said, and he suffers from muscle cramps, numbness in his legs, ringing in his ears, poor sleep, diabetes and other problems.